FDA Jobs in Minnesota

Refine Results
21 - 40 of 94 Jobs

Python Developer

Hired by Matrix, Inc.

•

Remote or Nutley, New Jersey, USA

Contract

At-a-Glance: Are you ready to build your career by joining a global pharmaceutical company. If so, our client is hiring a Python Developer.Position Type: Contract RemoteRequired: Master s degree with 8+ years of experience in clinical or pharma settings and 3+ years of experience in Python development Strong understanding of SDTM standards and CDISC requirements. Experience with AI/ML techniques, including data preprocessing, classification, and NLP (e.g., for mapping clinical terms). Familiarit
Easy Apply
Posted 3 days ago | Updated 10 hours ago

Principal Regulatory Consultant Dietary Supplements

Apptad Inc

•

New Jersey, USA

Contract, Third Party

Job Description: Job Title: Principal Regulatory Consultant Dietary Supplements (U.S.-Based) Position Type: Contract / Consulting Location: Jersey City, NJ Department: Regulatory Affairs / Corporate Development Position Summary: We are seeking a highly experienced and credentialed Regulatory Consultant to support strategic M&A due diligence initiatives within the dietary supplement industry. This role demands deep understanding of the U.S. regulatory landscape, including DSHEA, FDA cGMPs (21 CFR
Easy Apply
Posted 13 days ago

Document Management Specilist (W2 Only - 100% Remote)

Performix Business Services, LLC

•

Remote or Rochester, Minnesota, USA

Contract

Learn Division of Engineering tools and expectations.Document controls system (SolidWorks PDM) structure, navigation, and use.Engineering change order process.Document templates.Assist with document revisions from annual review. For each document:Accept redlines from document owner (facilitate review?).Review documents and suggest further incremental improvements.Verify reference documents section.Documents referenced in text are included in reference section.Documents in reference section exist
Easy Apply
Posted 6 days ago | Updated 5 days ago

Inspector II (W2 Only)

Generis TEK Inc.

•

Plymouth, Minnesota, USA

Contract

We have Contract role Inspector II (W2 Only) for our client at Plymouth MN. Please let me know if you or any of your friends would be interested in this position. Position Details: Inspector II (W2 Only) - Plymouth MN Location : Plymouth MN 55442 Project Duration : This is a 12 months contract with potential to extend highly likely Pay Rate : $17.00/hr. on W2 Hours : 1:00 PM 9:30 PM Job Description Primary Responsibilities: Perform visual, dimensional, and functional inspection and testing of pu
Easy Apply
Posted 4 days ago | Updated 3 hours ago

Principal Engineer

Katalyst Healthcares and Lifesciences

•

Plymouth, Minnesota, USA

Full-time

Job Description: This section focuses on the main purpose of the job in one to four sentences. Technical lead for DHF structure within sustaining engineering for disposable medical devices. Responsibilities: This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned. Manage a new 3rd-party supplier documentation strategy for peritoneal dialysis disposable sets. Manage change controls from init
Posted 11 days ago | Updated 3 hours ago

Sr. Biostatistician needed for Remote Job longterm Contract!!!

Nam Info Inc

•

Remote or US

Contract, Third Party

Dear, Hope you are doing well. Send resumes along with expected bill rates on W2( NO Benefits) or Independent contractors only apply and share to Note : NO 3rd party candidates, or H1's/EAD's/OPT's please. Role : Sr. Biostatistician Location:Remote Duration : 6+ months contract EST time zone- candidate need to work in EST time Skills: At least 8years of experience In Addition to the above Statistical Programming II experience Lead statistica
Easy Apply
Posted 2 days ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

•

Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. uthor and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's degree
Posted 11 days ago | Updated 3 hours ago

Laboratory Information Management System (LIMS) /ELN Consultant, MN/REMOTE - Direct Client

Javen Technologies, Inc

•

Remote

Third Party, Contract

Javen Technologies Direct Client is looking for Laboratory Information Management System (LIMS)/Electronic Lab Notebook (ELN) Consultant in Maplewood MN. 100% REMOTE opportunity. If interested, please reach me at / - Gowri. Domain Knowledge: Experience with LIMS (Laboratory Information Management Systems) preferably LabVantage Understanding of clinical, research, or diagnostic lab workflows Knowledge of regulatory requirements (GxP, FDA 21 CFR Part 11) Familiarity with lab instruments, integra
Easy Apply
Posted 3 days ago

IT Project Lead V - LIMS Project Manager

Javen Technologies, Inc

•

Remote

Third Party, Contract

Job Title: IT Project Lead V Location: Remote. Duration: 15+ Months (Extendable) Duties: This role will assist with the implementation of a new Laboratory Information Management System (LIMS) and Electronic Lab Notebook (ELN) to be used across the organization starting in 2026. Domain Knowledge: Experience with LIMS (Laboratory Information Management Systems) preferably LabVantageUnderstanding of clinical, research, or diagnostic lab workflowsKnowledge of regulatory requirements (GxP, FDA 21 CFR
Easy Apply
Posted 3 days ago

Statistical Programmer

System Edge (USA) L.L.C.

•

Remote

Contract

Statistical Programmer Anywhere in US EST time zone- candidate need to work in EST time Key responsibilities At least 5 years of experience in ADaM/TLF.Create, validate, and maintain SAS programs for data analysis, reporting, and submission deliverablesDevelop analysis datasets (ADaM) and tables, listings, and figures (TLFs) to support statistical analysis in production side.Collaborate with statisticians and data managers to define dataset specifications and outputsEnsure compliance with inter
Easy Apply
Posted 3 days ago

CQV Engineer

Katalyst Healthcares and Lifesciences

•

Remote or New Jersey, USA

Full-time

Job Description: We are seeking a highly motivated and experienced CQV Engineer to join PharmEng Technology, a leading global provider of engineering and consulting services to the pharmaceutical and biotechnology industries. The CQV Engineer will lead commissioning, qualification, and validation activities for new and existing pharmaceutical facilities and equipment. Responsibilities: Develop and execute commissioning, qualification, and validation protocols for new and existing pharmaceutical
Posted 7 days ago | Updated 3 hours ago

Remote QA Manager with Healthcare Payer and Claims exp

Infinite Computer Solutions (ICS)

•

Remote

Full-time

Note : GCEAD, L2EAD, consultant can apply for this position who can work on W2. Job Summary: We are looking for an experienced QA Healthcare Manager to lead the quality assurance team in ensuring the reliability, security, and compliance of healthcare applications. The ideal candidate should have a strong background in healthcare software testing, regulatory compliance (HIPAA, CMS, FDA), test automation, and team leadership. Key Responsibilities: we need someone who understand healthacre paye
Easy Apply
Posted 20 days ago | Updated 10 days ago

Senior Clinical SAS programmer with Pharma experience -Remonte-W2 -Contract

Biogensys

•

Remote

Contract

Biogensys is currently hiring a Senior SAS programmer with Pharma experience for 6 to 12 months contract on w2. This is a remote position, no corp to corp, or 1099. No sponsorship is available. Statistical Programmer II: Pharma experience/Remote At least 7-8 years of experience in ADaM/TLF.Create, validate, and maintain SAS programs for data analysis, reporting, and submission deliverablesDevelop analysis datasets (ADaM) and tables, listings, and figures (TLFs) to support statistical analysis in
Easy Apply
Posted 5 days ago

Sr. Principal Statistics

PARAKEET WORLD SOLUTIONS LLC

•

Remote

Contract

Job Title: Sr. Principal StatisticsLocation: Remote Duration: 6 MonthsEmployment Type: W2 ContractExperience Level: Mid-SeniorEducation Required: Ph.D. or MS in Statistics or BiostatisticsIndustry: Pharmaceuticals Job Summary:The Sr. Principal Statistician will lead statistical activities in clinical trials, from protocol development to final study reporting. The role will also contribute to regulatory filings, in-licensing evaluations, and marketing support. Key Responsibilities:Review protocol
Easy Apply
Posted 19 days ago

Engineer Disposables R&D, Sustaining

Stefanini

•

Plymouth, Minnesota, USA

Contract

Stefanini Group is hiring! Stefanini is looking for Engineer - Disposables R&D, Sustaining in Plymouth, MN (Hybrid) For quick Apply, please reach out to Vipul Bhardwaj - call: / email: Work Hours: M-F (40 hours) Work Location: Plymouth, MN (Hybrid) Shift: 1st Shift Create new 3rd party supplier documentation including design specifications, labeling, design drawings, etc. for peritoneal dialysis disposable sets.Create, modify, and maintain design history files.Perform change control assessments.
Easy Apply
Posted 16 days ago | Updated moments ago

Principal Engineer Disposables R&D, Sustaining

Stefanini

•

Plymouth, Minnesota, USA

Contract

Stefanini Group is hiring! Stefanini is looking for Principal Engineer - Disposables R&D, Sustaining in Plymouth, MN (Hybrid) For quick Apply, please reach out to Tuhin Podder- call: /email: Work Hours: M-F (40 hours) Work Location: Plymouth, MN (Hybrid) Shift: 1st Shift Technical lead for DHF structure within sustaining engineering for disposable medical devices.Manage new 3rd party supplier documentation strategy for peritoneal dialysis disposable sets.Manage change controls from initiation th
Easy Apply
Posted 16 days ago | Updated moments ago

Statistical Programmer needed for Remote Job only EST candidates needed!!!

Nam Info Inc

•

Remote or US

Full-time, Contract, Third Party

Dear, Hope you are doing well. Send resumes along with expected bill rates on W2( NO Benefits) or Independent contractors only apply and share to Note : NO 3rd party candidates, or H1's/EAD's/OPT's please. Role :Statistical Programmer II Location :Remote Duration : 6+ months contract EST ZONE CANDIDATES ONLY Statistical Programming II: Key responsibilities At least 5 years of experience in ADaM/TLF. Create, validate, and maintain SAS programs for data analysis, reporting, and submission de
Easy Apply
Posted 2 days ago

Validation Engineer III

Katalyst Healthcares and Lifesciences

•

Mounds View, Minnesota, USA

Full-time

Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Perform, oversee, and guide supplier process validations (IQ/OQ/PQ) for sterile barrier packaging material manufacturing processes. Ensure supplier process validation requirements (CTQs, drawings, specifications, risk levels, and protocols) are communicated, understood, and executed. Collaborate with suppliers to review and approve validation documentation, including prot
Posted 60+ days ago | Updated 3 hours ago

Clinical Data manager

Intone Networks Inc.

•

Remote

Third Party, Contract

Need stronger with working on Data Acquisition, DTAs and vendor relations. Responsibilities: Support the planning, setup, and acquisition of external clinical data at the study level, assisting in managing study start-up, conduct, and closeout activities.Assist in creating external data transfer agreements, ensuring alignment with Takeda Standards and specifications to support data integration, analysis, and reporting.Provide support in setting up infrastructure for external data to flow into T
Easy Apply
Posted 9 days ago | Updated 3 days ago

Sales head

Showman Staffing

•

Remote

Full-time

Job Title: Sales Head Experience: 6+yrs Location: Remote-Travel required-100% client location Job: Permanent Full Time Requirement Role Overview We are seeking a passionate and driven Sales professional to accelerate our growth in the Healthcare and MedTech space one of the most rapidly evolving sectors today. You will work with a high performing team targeting innovative healthcare providers, MedTech firms, and digital health disruptors to bring cutting-edge technology solutions to life. You w
Easy Apply
Posted 2 days ago